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TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB
This study has been completed.
Sponsor:
Centers for Disease Control and Prevention
Collaborator:
VA Office of Research and Development
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00023348
First received: September 6, 2001
Last updated: September 9, 2005
Last verified: September 2005
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Purpose
Primary Objectives:
1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.
Secondary Objectives:
- To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin.
- To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
- To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
- To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections Tuberculosis | Drug: Isoniazid Drug: Rifabutin | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in USPHS Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen |
Resource links provided by NLM:
Further study details as provided by Centers for Disease Control and Prevention:
Primary Outcome Measures:
- To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.
Secondary Outcome Measures:
- 1) To determine risk factors for abnormal pharmacokinetics of isoniazid and rifabutin
- 2) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
- 3) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
- 4) To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.
| Estimated Enrollment: | 150 |
| Study Start Date: | July 1999 |
| Estimated Study Completion Date: | November 2002 |
This study will seek to enroll every eligible patient enrolled in TBTC Study 23. Consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion:
- Patient enrolled in TBTC Study 23
- Informed consent
Exclusion:
1. Severe anemia (Hct <25%)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00023348
Show 23 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023348
Show 23 Study Locations
Sponsors and Collaborators
Centers for Disease Control and Prevention
VA Office of Research and Development
Investigators
| Principal Investigator: | Marc Weiner, MD | Audie L. Murphy VA Medical Center, San Antonio TX |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00023348 History of Changes |
| Other Study ID Numbers: |
CDC-NCHSTP-2173 23A |
| Study First Received: | September 6, 2001 |
| Last Updated: | September 9, 2005 |
Keywords provided by Centers for Disease Control and Prevention:
|
Tuberculosis TB |
Additional relevant MeSH terms:
|
HIV Infections Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Isoniazid Rifabutin Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Antibiotics, Antitubercular |
ClinicalTrials.gov processed this record on September 21, 2017